Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rosacea
Intervention: Metronidazole gel 1% (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, LP
Summary
This eight-hour kinetic regression clinical study was conducted to assess the ability of
MetroGel® 1% to deliver moisture to facial skin after a single application.
Clinical Details
Official title: MetroGel 1% Hydration Study: A Kinetic Regression Study
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Six replicate Corneometer CM 825 measurements
Secondary outcome: Adverse events
Detailed description:
This eight-hour kinetic regression clinical study was conducted to assess the ability of
MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the
Corneometer CM 825.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Clinical diagnosis of moderate to severe rosacea, defined as the presence of at least
moderate erythema with telangiectasia and a minimum of two inflammatory lesions
Exclusion Criteria:
- Individuals with active symptoms of allergy (mild active seasonal allergies are
acceptable) or atopic dermatitis
Locations and Contacts
Colorado Springs Research Center, Colorado Springs, Colorado 80915, United States
Additional Information
Starting date: August 2006
Ending date: August 2006
Last updated: April 11, 2008
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